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Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
NCT04886531 · View on ClinicalTrials.gov ↗
Study Summary
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Neratinib
- DRUG Letrozole (L) or Anastrozole (A)
Study Locations (4)
Illinois
- University of Illinois Cancer Center — Chicago
New York
- University of Rochester Medical Center — Rochester
Pennsylvania
- Penn State Cancer Institute — Hershey
Wisconsin
- University of Wisconsin — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-07-21 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04886531
The ClinicalTrials.gov registry entry for NCT04886531 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ruth O'Regan, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04886531 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Illinois, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04886531 about?
NCT04886531 is a clinical study titled "Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers". Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of wee...
What is the current status of trial NCT04886531?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-07-21. Estimated completion is 2027-07.
What conditions does trial NCT04886531 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04886531?
The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Letrozole (L) or Anastrozole (A) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04886531?
This trial is sponsored by Ruth O'Regan, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04886531 being conducted?
This trial has 4 study locations across Illinois, New York, Pennsylvania, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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